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NCT04869501 Clinical Trial

Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer

Cancer Clinical Trial

Official title:
Expanded Access Protocol for an Intermediate Size Population-use of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04869501
Other study ID # TJ004309STM104
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date April 2023
Source I-Mab Biopharma Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This expanded access protocol was designed to provide TJ004309 in combination with atezolizumab to the remaining three patients with advanced or metastatic cancer who plan to continue with treatment.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Participation in the Tracon sponsored 4309ST101 or I-Mab sponsored TJ004309STM103 study and thought to have potential to derive clinical benefit from continued treatment in the opinion of the parent study investigator from dosing of TJ004309 in combination with atezolizumab. 2. Willing or able to comply with study treatment and standard of care testing and procedures. Exclusion Criteria: 1. Any unresolved ongoing toxicity or clinical event that would make continued treatment with TJ004309 inappropriate. 2. Current treatment in another clinical study or treatment with other standard of care therapy. 3. Currently pregnant. 4. Current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might interfere with the patient's participation or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TJ004309
Antibody to CD73
• Atezolizumab
Humanized monoclonal antibody to PD-L1

Locations
Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States HonorHealth Research Institute Scottsdale Arizona
United States Arizona Oncology Associates, P.C. Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
I-Mab Biopharma US Limited

Country where clinical trial is conducted

United States, 

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